FDA added a Boxed Warning to glatiramer acetate labeling for anaphylaxis (Jan 2025)
The post points to methylmalonic acid and homocysteine as more sensitive markers of tissue-level B12 status than a serum B12 reading on its own
Neurochemical Research, 23 , 667-673
As a GLP-1 agonist, the drug semaglutide was already used as an injection for diabetes and weight loss
The purpose of the NDA is to provide FDA reviewers with enough information to make the following key decisions: Comprehending whether the drug is safe and effective in its proposed use(s) Comprehending whether the benefits of the drug outweigh the risks Determining whether the drug's submitted labeling (package insert) is appropriate, and what it should include Determining whether the methods used in manufacturing the drug and the controls used to maintain its quality are sufficient to maintain the drug's identity, strength, quality, and purity
Not following these instructions can make Rybelsus less effective or more likely to cause side effects